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Completed

NCT Number: NCT06044532

SKAMo-1: Characterization of the Upper Layers of Skin

Diabetes is a frequent disease characterized by chronic hyperglycemia, and its prevalence is increasing worldwide. Historically, patients with diabetes were required to monitor capillary blood glucose concentration up to several times a day through fingertip sampling.

Recently marketed devices now allow measurements of interstitial fluid blood glucose continuously, thus limiting pain associated with sampling. However, they are still invasive and have to be changed every 14 days.

Therefore, to optimize continuous glycemia monitoring while avoiding pain, discomfort, and the risk of infection, non-invasive methods are needed. Among the different strategies being developed, optical wearable sensors with specific signal processing are a promising option. The sensors detecting this optical signal will be included in a device. Yet, wearing a device may slightly modify several properties of the skin, such as its humidity and thermal regulation, and subsequently have an impact on the measured optical signal. Therefore, it is important to better understand how a device affects these characteristics to include these parameters in the future device algorithms.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Grenoble Alpes

Grenoble, 38043, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female aged ≥ 18 years and ≤ 60 years
  • Signed informed consent
  • Person who is affiliated to a social security scheme or who is beneficiary of such a scheme

Exclusion criteria

  • Body mass index (BMI) > 30 kg/m2
  • Any acute or chronic disease with vascular impact
  • Any cutaneous disease on sites implicated in the study (dorsum of the forearm)
  • Allergy to one of the material used in the sham device and during the procedure of the study
  • The persons mentioned in articles L1121-5 to L1121-8 of the public health code may not be included in this research
  • Subject who would receive more than 4500 euros in compensation due to his or her participation in other research involving the human person in the 12 months preceding this study

Treatment and study plan

Experimental

Other

At the first visit, effects of skin preparations (cleaning or sanding) on skin parameters and wearing a sham device will be evaluated. At the second visit the effect on skin parameters of a local heating and an OGTT will be evaluated.

Primary outcomes

  1. Change of skin hydration on the dorsum of the forearm after two and a half hours of wearing the sham device.

    Time frame: Visit 1,Day 0, before and after two and a half hours of wearing the sham device

    Hydration is measured with a capacitance method, expressed as arbitrary units (dielectric value)

Secondary outcomes

  1. Change of skin elasticity after the wearing the sham device

    Time frame: Visit 1,Day 0, before and after two and a half hours of wearing the sham device

    elasticity (suction method) expressed as penetration depth in mm/time

  2. Change of transepidermal water loss after the wearing the sham device

    Time frame: Visit 1,Day 0, before and after two and a half hours of wearing the sham device

    transepidermal water loss (the density gradient of the water evaporation) expressed as the evaporation rate in g/h/m2

  3. Change of thickness of the stratum corneum after the wearing the sham device

    Time frame: Visit 1,Day 0, before and after two and a half hours of wearing the sham device

    thickness of the stratum corneum (LC-OCT method) expressed as mm

  4. Change of skin temperature after the wearing the sham device

    Time frame: Visit 1,Day 0, before and after two and a half hours of wearing the sham device

    skin temperature (infrared thermography) expressed as Celsius,

  5. Change of skin blood flux after the wearing the sham device

    Time frame: Visit 1,Day 0, before and after two and a half hours of wearing the sham device

    skin blood flux (LSCI) expressed as an arbitrary unit,

  6. Change of skin hydration after skin cleaning

    Time frame: Visit 1, Day 0, in 30 minutes, measures taken before and after skin cleaning

    expressed as previously described

  7. Change of skin elasticity after skin cleaning

    Time frame: Visit 1, Day 0, in 30 minutes, measures taken before and after skin cleaning

    expressed as previously described

  8. Change of transepidermal water loss after skin cleaning

    Time frame: Visit 1, Day 0, in 30 minutes, measures taken before and after skin cleaning

    expressed as previously described

  9. Change of thickness of the stratum corneum after skin cleaning

    Time frame: Visit 1, Day 0, in 30 minutes, measures taken before and after skin cleaning

    expressed as previously described

  10. Change of skin temperature after skin cleaning

    Time frame: Visit 1, Day 0, in 30 minutes, measures taken before and after skin cleaning

    expressed as previously described

  11. Change of skin blood flux after skin cleaning

    Time frame: Visit 1, Day 0, in 30 minutes, measures taken before and after skin cleaning

    expressed as previously described

  12. Change of skin hydration after skin sanding

    Time frame: Visit 1, Day 0, in 30 minutes, measures taken before and after skin sanding

    expressed as previously described

  13. Change of skin elasticity after skin sanding

    Time frame: Visit 1, Day 0, in 30 minutes, measures taken before and after skin sanding

    expressed as previously described

  14. Change of transepidermal water loss after skin sanding

    Time frame: Visit 1, Day 0, in 30 minutes, measures taken before and after skin sanding

    expressed as previously described

  15. Change of thickness of the stratum corneum after skin sanding

    Time frame: Visit 1, Day 0, in 30 minutes, measures taken before and after skin sanding

    expressed as previously described

  16. Change of skin temperature after skin sanding

    Time frame: Visit 1, Day 0, in 30 minutes, measures taken before and after skin sanding

    expressed as previously described

  17. Change of skin blood flux after skin sanding

    Time frame: Visit 1, Day 0, in 30 minutes, measures taken before and after skin sanding

    expressed as previously described

  18. Change of skin hydration after local heating

    Time frame: Visit 2, Day 7 (+/-6 days), before and after local heating (40 minutes local thermal heating between 33 to 43°C with probes PF457)

    expressed as previously described

  19. Change of skin elasticity after local heating

    Time frame: Visit 2, Day 7 (+/-6 days), before and after local heating (40 minutes local thermal heating between 33 to 43°C with probes PF457)

    expressed as previously described

  20. Change of transepidermal water loss after local heating

    Time frame: Visit 2, Day 7 (+/-6 days) before and after local heating (40 minutes local thermal heating between 33 to 43°C with probes PF457)

    expressed as previously described

  21. Change of thickness of the stratum corneum after local heating

    Time frame: Visit 2, Day 7 (+/-6 days) before and after local heating (40 minutes local thermal heating between 33 to 43°C with probes PF457)

    expressed as previously described

  22. Change of skin temperature after local heating

    Time frame: Visit 2, Day 7 (+/-6 days) before and after local heating (40 minutes local thermal heating between 33 to 43°C with probes PF457)

    expressed as previously described

  23. Change of skin blood flux after local heating

    Time frame: Visit 2, Day 7 (+/-6 days) before and after local heating (40 minutes local thermal heating between 33 to 43°C with probes PF457)

    expressed as previously described

  24. Change of skin hydration induced by oral glycemia tolerance test

    Time frame: Visit 2, Day 7 (+/-6 days), before and during oral glycemia tolerance test (every 15 minutes for 2 hours)

    expressed as previously described

  25. Change of skin elasticity induced by oral glycemia tolerance test

    Time frame: Visit 2, Day 7 (+/-6 days), before and during oral glycemia tolerance test (every 15 minutes for 2 hours)

    expressed as previously described

  26. Change of transepidermal water loss induced by oral glycemia tolerance test

    Time frame: Visit 2, Day 7 (+/-6 days), before and during oral glycemia tolerance test (every 15 minutes for 2 hours)

    expressed as previously described

  27. Change of thickness of the stratum corneum induced by oral glycemia tolerance test

    Time frame: Visit 2, Day 7 (+/-6 days), before and during oral glycemia tolerance test (every 15 minutes for 2 hours)

    expressed as previously described

  28. Change of skin temperature induced by oral glycemia tolerance test

    Time frame: Visit 2, Day 7 (+/-6 days), before and during oral glycemia tolerance test (every 15 minutes for 2 hours)

    expressed as previously described

  29. Change of skin blood flux induced by oral glycemia tolerance test

    Time frame: Visit 2, Day 7 (+/-6 days), before and during oral glycemia tolerance test (every 15 minutes for 2 hours)

    expressed as previously described

Sponsors and collaborators

Lead sponsor

Eclypia

Industry

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Sep 21, 2023
Registry last updated
Sep 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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